An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
This research is looking into a new medication, PIT565, for individuals living with Systemic Lupus Erythematosus (SLE). The main goals are to find out if PIT565 is safe to use, how well your body tolerates it, and how it moves through and leaves your system. Researchers also want to discover the right amount of medicine to give. This is a very early study (Phase 1), meaning it's one of the first times this medicine is being tested in people. The medicine will be given as an injection under the skin. As the study progresses, the dose may slowly increase to find the most effective and safest amount, while carefully checking for any side effects.
En un coup d'œil
De quoi parle cette étude ?
This study is about a new medicine called PIT565 for Systemic Lupus Erythematosus (SLE), or lupus. Lupus is a long-term condition that causes the body's immune system to mistakenly attack its own tissues and organs. Researchers are trying to find new ways to treat it.
In this study, the medicine PIT565 will be given as an injection just under the skin. This is an early-stage study, which means it's one of the first times PIT565 is being tried in people. The main aims are to see how safe it is, how your body reacts to it, and how much of it is needed to be effective. The dose of the medicine may be gradually increased for different groups of participants, but only if it's considered safe to do so.
The study will start with small groups of people, and if the medicine seems safe and shows some helpful effects, more people might join later at specific dose levels. This careful approach helps researchers understand the new medicine step-by-step, ensuring participant safety is always the top priority.
Points clés
- This is an early study (Phase 1) looking at a new lupus medicine called PIT565.
- The main goals are to check the medicine's safety, how it's handled by the body, and the right dose.
- PIT565 is given as an injection under the skin.
- Participants must have active lupus that isn't responding well to current treatments.
- Careful monitoring and safety checks are a big part of the study.
Qui peut être éligible ?
To join this study, you must be between 18 and 75 years old and have been diagnosed with lupus (SLE) using specific medical guidelines. Your lupus should also be active, meaning you are currently experiencing symptoms, and your current lupus treatments should not be working well enough.
You would not be able to join if you have very severe lupus that has caused significant organ damage or is life-threatening, or if you are having a serious flare-up that needs immediate treatment. Also, if you have severe kidney problems related to lupus that require strong medication, you might not be suitable. Other conditions like serious heart problems, certain severe infections (like HIV or hepatitis), or other serious medical illnesses could also prevent you from taking part.
Women who could become pregnant would need to be using very reliable birth control methods to be considered for the study.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Avez-vous entre 18 et 75 ans ?
- Do you have a confirmed diagnosis of lupus (SLE)?
- Is your lupus currently active, despite your usual treatments?
- Have you been vaccinated against common infections like flu and COVID-19?
- Do you have any severe organ damage or life-threatening lupus flares?
- If you are a woman, are you able to use effective birth control?
En quoi consiste la participation ?
If you decide to take part, you would receive the study medicine, PIT565, as an injection under your skin. Before each dose, you might receive other medicines to help prevent any reactions. The study involves different groups of people, and the dose of PIT565 might be different for each group, starting low and possibly increasing if it's safe.
The researchers will closely monitor your health and any effects of the medicine. This will involve regular visits to the clinic for check-ups, blood tests, and other assessments. The total time you would be involved in the study is not specified, but early-stage studies like this often involve several weeks or months of close monitoring.
Risques et avantages potentiels
Locations (13)
- Site d'Investigation NovartisCode postal vérifiéSofia, Bulgaria· Retiré
- Site d'Investigation NovartisCode postal vérifiéPékin, Chine· Recrutement
- Site d'Investigation NovartisCode postal vérifiéPékin, Chine· Recrutement
- Site d'Investigation NovartisCode postal vérifiéBerlin, Allemagne· Recrutement
- Site d'Investigation NovartisCode postal vérifiéMainz, Allemagne· Recrutement
- Site d'Investigation NovartisCode postal vérifiéBudapest, Hungary· Recrutement
- Site d'Investigation NovartisCode postal vérifiéSzeged, Hungary· Recrutement
- Site d'Investigation NovartisCode postal vérifiéLeiden, Netherlands· Recrutement
- Site d'Investigation NovartisVille uniquementSantiago Compostela, Spain· Recrutement
- Site d'Investigation NovartisCode postal vérifiéBarcelona, Spain· Recrutement
- Site d'Investigation NovartisCode postal vérifiéMadrid, Spain· Recrutement
- Site d'Investigation NovartisCode postal vérifiéBern, Switzerland· Recrutement
Questions fréquentes
What is PIT565?
PIT565 is a new medicine being tested for people with lupus (SLE). It's in the early stages of development.
Pourquoi cette étude est-elle importante ?
This study helps researchers understand if PIT565 is safe and how it works in the body, which could lead to a new treatment option for lupus.
Will I know if I'm getting the actual medicine?
Yes, everyone in this study will receive PIT565. There isn't a placebo (dummy medicine) group.
Comment le médicament sera-t-il administré ?
The medicine PIT565 will be given as an injection just under the skin.
Que faire si je me sens mal pendant l'étude ?
Your health will be closely monitored, and you can withdraw from the study at any time if you feel unwell or for any other reason.
Comment en savoir plus
Novartis Pharmaceutiques
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Intéressé à participer ?
Discussion
Discussion communautaire
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